Optimization of Tocilizumab Therapy in Giant Cell Arteritis: A Multicenter Real Life Study of 134 Patients

Mónica Calderón-Goercke¹, Javier Loricera ², DIANA PRIETO- PENA ³, Santos Castañeda ⁴, Vicente Aldasoro Caceres ⁵, Ignacio Villa ⁶, Alicia Humbría ⁷, Clara Moriano ⁸, Susana Romero-Yuste ⁹, Javier Narváez ¹⁰, Catalina Gómez-Arango ¹¹, Eva Perez Pampín ¹², Rafael Melero ¹³, Elena Becerra-Fernández ¹⁴, Marcelino Revenga ¹⁵, Noelia Álvarez-Rivas ¹⁶, Carles Galisteo ¹⁷, Francisca Sivera ¹⁸, Alejandro Olivé-Marqués ¹⁹, María Álvarez del buergo ²⁰, Luisa Marena-Rojas ²¹, Carlos Fernández-López ²², Francisco Navarro ²³, E. Raya ²⁴, Eva Galindez-Agirregoikoa ²⁵, Beatriz Arca ²⁶, Roser Solans-Laqué ²⁷, Arantxa Conesa ²⁸, Cristina Hidalgo ²⁹, Carlos Vazquez ³⁰, Jose Andrés Román-Ivorra ³¹, Pau Lluch ³², Sara Manrique ³³, P. Vela ³⁴, Eugenio de Miguel ³⁵, Carmen Torres-Martín ³⁶, Juan Carlos Nieto ³⁷, Carmen Ordas-Calvo ³⁸, Eva salgado-Pérez ³⁹, Cristina Luna-Gómez ⁴⁰, F. Javier Toyos-Sáenz De Miera ⁴¹, Nagore Fernández-Llanio ⁴², Antonio García ⁴³, Carmen Larena ⁴⁴, María Varela-García ⁵, Elena Aurrecoechea ⁶, Francisco Ortiz-Sanjuán ³¹, Jose Luis Hernández ¹, Miguel Angel González-Gay ⁴⁵ and Ricardo Blanco ⁴⁶, ¹Hospital Marqués de Valdecilla, Santander, Cantabria, Spain, ²Rheumatology Department. Hospital Marqués de Valdecilla, Santander, Cantabria, Spain, ³Rheumatology, Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain, ⁴Rheumatology Department, Hospital Universitario de la Princesa, IIS-Princesa, Madrid, Spain, Madrid, Spain, ⁵Complejo Hospitalario de Navarra, Navarra, Navarra, Spain, ⁶Hospital de Sierrallana, Torrelavega, Cantabria, Spain, ⁷Hospital de La Princesa, Madrid, Madrid, Spain, ⁸Complejo Asistencial Universitario de León, León, Castilla y Leon, Spain, ⁹Complejo Hospitalario Universitario Pontevedra, Pontevedra, Galicia, Spain, ¹⁰Rheumatology Department, Hospital Universitario de Bellvitge, Barcelona, Spain, Barcelona, Catalonia, Spain, ¹¹Hospital Alto Deba, Mondragon, Pais Vasco, Spain, ¹²Division of Rheumatology, Instituto de Investigación Sanitaria-Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, Santiago de Compostela, Spain, ¹³Complexo Hospitalario Universitario de Vigo, Vigo, Galicia, Spain, ¹⁴Hospital de Torrevieja, Alicante, Comunidad Valenciana, Spain, ¹⁵Hospital Ramón y Cajal, Madrid, Madrid, Spain, ¹⁶Hospital Universitario Lucus Augusti, Lugo, Galicia, Spain, ¹⁷Hospital Parc Taulí, Barcelona, Catalonia, Spain, ¹⁸Hospital General Universitario de Elda, Elda, Spain, ¹⁹Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain, ²⁰Hospital Río Carrión, Palencia, Castilla y Leon, Spain, ²¹Hospital La Mancha Centro, Alcázar de San Juan, Castilla-La Mancha, Spain, ²²Servicio de Reumatología. Instituto de Investigación Biomédica de A Coruña (INIBIC). Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC). As Xubias, 15006. A Coruña, España, A Coruña, Spain, ²³Hospital General Universitario de Elche, Alicante, Comunidad Valenciana, Spain, ²⁴Hospital San Cecilio, Granada, Andalucia, Spain, ²⁵Hospital de Basurto, Bilbao, Pais Vasco, Spain, ²⁶Hospital Universitario San Agustín, Avilés, Asturias, Spain, ²⁷Department of Internal Medicine, Hospital Vall d'Hebron, Barcelona, Spain., Barcelona, Catalonia, Spain, ²⁸Hospital General Universitario de Castellón, Castellón, Comunidad Valenciana, Spain, ²⁹Hospital Clínico Universitario de Salamanca, Salamanca, Castilla y Leon, Spain, ³⁰Hospital Miguel Servet, Zaragoza, Aragon, Spain, ³¹Hospital Universitario y Politécnico La Fe, Valencia, Comunidad Valenciana, Spain, ³²Hospital Mateu Orfila, Menorca, Islas Baleares, Spain, ³³Hospital Regional de Málaga, Málaga, Andalucia, Spain, ³⁴Hospital General Universitario de Alicante, Alicante, Comunidad Valenciana, Spain, ³⁵Rheumatology Department, Hospital Universitario La Paz, Madrid, Spain, ³⁶Complejo Asistencial de Ávila, Ávila, Castilla y Leon, Spain, ³⁷Rheumatology Department. Hospital Gregorio Marañón, Madrid, Madrid, Spain, ³⁸Hospital Cabueñes, Gijón, Asturias, Spain, ³⁹Complejo Hospitalario Universitario de Ourense, Ourense, Galicia, Spain, ⁴⁰Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Canarias, Spain, ⁴¹Hospital Universitario Virgen Macarena, Sevilla, Andalucia, Spain, ⁴²Hospital Arnau de Vilanova, Lérida, Catalonia, Spain, ⁴³Hospital Virgen de las Nieves, Granada, Andalucia, Spain, ⁴⁴Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain, ⁴⁵Universidad de Cantabria and IDIVAL, Hospital Universitario Marqués de Valdecilla, Santander, Spain, ⁴⁶Rheumatology, Hospital Universitario Marques de Valdecilla, Santander, Spain

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: optimization and giant cell arteritis, Tocilizumab

Session Information

Date: Tuesday, November 12, 2019

Title: Vasculitis – Non-ANCA-Associated & Related Disorders Poster III: Giant Cell Arteritis

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Tocilizumab (TCZ) is the only biological agent approved in Giant Cell Arteritis (GCA). There is general agreement on the initial and the standard maintenance dose of TCZ. However, information on duration and optimization of TCZ in GCA is scarce.
Our aim was to assess efficacy and safety of TCZ therapy optimization in an unselected wide series of GCA in clinical practice.

Methods: Multicenter study on 134 patients with GCA who received TCZ therapy due to inefficacy or adverse events of previous therapy. Once complete remission was reached and based on a shared decision between the patient and the physician TCZ was optimized in some cases. Complete remission was defined as normalization of clinical an analytical (CRP and ESR) findings. Optimization was done by decreasing the dose and/or prolonging the TCZ dosing interval progressively. We performed a comparison between optimized and non-optimized patients.

Results: We evaluated 134 GCA patients treated with TCZ (101 women/33 men); mean age 73.0±8.8 years. TCZ was administered IV to 106 (79.1%) patients and SC to 28 (20.9%). The initial dose was 8 mg/kg/IV/4 weeks or 162 mg/SC/week, respectively. TCZ was optimized in 42 (31.3%) patients. No demographic, clinical manifestations or laboratory data differences had been found at TCZ onset between both groups (TABLE1). After a median [25-75th] follow up of 12 [6-15.5] months, and in a complete remission for 6 [3-12] months; the first TCZ optimization was performed in the optimized group. The median prednisone dose at first TCZ optimization was 2.5 [0-5] mg/day. TCZ IV was optimized from 8 to 4 mg/kg/4 weeks in 11 of 106 (10.4%) and from 162 mg/SC/week to 162 mg/SC/2 weeks in 9 of 28 (32.1%) cases. In TABLE 2 data of the optimized doses. Five (11.9%) of the 42 optimized cases relapsed. In 4 of these cases, the relapses were treated increasing TCZ up to the pre-optimization dose, and in 1 case the route of administration of TCZ was change (4 mg/kg/4week to 162 mg/SC/week). In 8 of 42 optimized patients (19%), it was possible to withdraw TCZ after complete remission for 30 [16.25-45.75] months. Regarding adverse events, severe infections were less frequent in the optimized group (14.3% vs 11%) with non-statistical significance.

Conclusion: Once remission is reached in GCA patients under TCZ treatment, optimization of TCZ may be performed. Based on our experience it could be performed by reducing the dose with IV TCZ or by prolonging dosing interval with SC TCZ. It seems to be effective and safe.

TABLE Optimization -1-

TABLE Optimization -3-

Disclosure: M. Calderón-Goercke, None; J. Loricera, None; D. PRIETO- PENA, None; S. Castañeda, None; V. Aldasoro Caceres, None; I. Villa, None; A. Humbría, None; C. Moriano, None; S. Romero-Yuste, None; J. Narváez, None; C. Gómez-Arango, None; E. Perez Pampín, None; R. Melero, None; E. Becerra-Fernández, None; M. Revenga, None; N. Álvarez-Rivas, None; C. Galisteo, None; F. Sivera, None; A. Olivé-Marqués, None; M. Álvarez del buergo, None; L. Marena-Rojas, None; C. Fernández-López, None; F. Navarro, None; E. Raya, None; E. Galindez-Agirregoikoa, None; B. Arca, None; R. Solans-Laqué, None; A. Conesa, None; C. Hidalgo, None; C. Vazquez, None; J. Román-Ivorra, None; P. Lluch, None; S. Manrique, None; P. Vela, None; E. de Miguel, AbbVie, 2, 5, 8, BMS, 8, BMS, MSD, UCB, Roche, 8, MSD, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 8, UCB, 8; C. Torres-Martín, None; J. Nieto, None; C. Ordas-Calvo, None; E. salgado-Pérez, None; C. Luna-Gómez, None; F. Toyos-Sáenz De Miera, None; N. Fernández-Llanio, None; A. García, None; C. Larena, None; M. Varela-García, None; E. Aurrecoechea, None; F. Ortiz-Sanjuán, None; J. Hernández, None; M. González-Gay, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Celgene, 5, 8, Eli Lilly, 2, 5, EliLilly, 2, 5, Jansen, 2, Janssen, 2, MSD, 2, 5, 8, Novartis, 2, 5, Pfizer, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, 8, Sobi, 5, 8; R. Blanco, None.

To cite this abstract in AMA style:

Calderón-Goercke M, Loricera J, PRIETO- PENA D, Castañeda S, Aldasoro Caceres V, Villa I, Humbría A, Moriano C, Romero-Yuste S, Narváez J, Gómez-Arango C, Perez Pampín E, Melero R, Becerra-Fernández E, Revenga M, Álvarez-Rivas N, Galisteo C, Sivera F, Olivé-Marqués A, Álvarez del buergo M, Marena-Rojas L, Fernández-López C, Navarro F, Raya E, Galindez-Agirregoikoa E, Arca B, Solans-Laqué R, Conesa A, Hidalgo C, Vazquez C, Román-Ivorra J, Lluch P, Manrique S, Vela P, de Miguel E, Torres-Martín C, Nieto J, Ordas-Calvo C, salgado-Pérez E, Luna-Gómez C, Toyos-Sáenz De Miera F, Fernández-Llanio N, García A, Larena C, Varela-García M, Aurrecoechea E, Ortiz-Sanjuán F, Hernández J, González-Gay M, Blanco R. Optimization of Tocilizumab Therapy in Giant Cell Arteritis: A Multicenter Real Life Study of 134 Patients [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/optimization-of-tocilizumab-therapy-in-giant-cell-arteritis-a-multicenter-real-life-study-of-134-patients/. Accessed .

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